Colitis, UlcerativePhase 4SCILLANCT03151525
Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis
A Phase 4 study testing Azathioprine and Infliximab in people with Colitis, Ulcerative, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA). Each patient will be followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Azathioprine and Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2017to 3 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 -65 years
- Written informed consent and willing to adhere to study procedures.
- Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (a maximum interval between two infusions of ± 3 weeks is allowed)
- Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
- Global Mayo score at baseline ≤ 2
- All Mayo subscores ≤ 1
- Absence of rectal bleeding
- Effective methods to avoid pregnancy during the study period
Who cannot join
- Disabling and persisting extraintestinal manifestation at baseline
- Patients unable to comply with study procedures
- Known intolerance or previous allergic reaction to thiopurines
- Concomitant therapy with allopurinol
- Any disease not compatible with the use of infliximab or azathioprine, as per clinician's judgement.
- Need for dose escalation of infliximab in the last 12 months prior to baseline.
- White blood cell count < 3000/mmc or absolute clinically relevant lymphopenia at baseline
- Active pregnancy or breastfeeding; willing for pregnancy during the study period
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IBD Center
Rozzano, MI, 20089
Silvio Danese, MD, PhD, 0039028224 ext. 5555, IBDclinicaltrials@humanitas.it
Gionata Fiorino, MD, PhD, 0039028224 ext. 5555, gionata.fiorino@humanitas.it
About this study
Official title: Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA).
Each patient will be followed for 12 months.
Read the detailed description
All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.
Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.
Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.
- Conditions
- Colitis, Ulcerative
- Being tested
- Azathioprine, Infliximab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
AZA treatment after IFX withdrawal for maintenance of remission
InfliximabDrug
IFX treatment for maintenance of remission
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine | Experimental | Azathioprine 2-2.5 mg/kg/day, according to approved indication Receives: Drug: Azathioprine |
| Infliximab | Active comparator | Infliximab 5 mg/kg every 8 weeks Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
relapse rate in the two study groups.
Measured: 12 months
Secondary outcomes (4)
Relapse time
Mean time to relapse in the two groups
Measured: 12 months
Number of adverse events [Safety and Tolerability]
Number of adverse events of the two study strategies
Measured: 12 months
Number of serious adverse events [Safety and Tolerability]
Number of serious adverse events of the two study strategies
Measured: 12 months
Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined
Potential risk factor for relapse will be evaluated by univariable analysis, and a multivariable analysis will be performed for all factors with p<0.30. Risk factors will be also analysed by logistic regression. Analysis of predetermined baseline characteristics (age, sex, smoking habits, histological healing of mucosa at baseline, and each Mayo subscore (stool number, presence of blood, colonic ulcerations) excluding the physician global assessment) to identify predictive factors for relapse.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start8 May 2017
- Primary completion3 Oct 2019 (estimated)
- Study completion3 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel two-arm prospective open-label study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151525
- Sponsor's protocol ID
- 1685
- Acronym
- SCILLA
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
PubMed 40013523
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab
- ClinicalTrials.gov ID
- NCT03151525
- Acronym / sponsor ID
- SCILLA / 1685
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- 8 May 2017 (actual)
- Primary completion
- 3 Oct 2019 (estimated)
- Study completion
- 3 Apr 2020 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA).
Each patient will be followed for 12 months.
Detailed description
All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.
Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.
Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel two-arm prospective open-label study
| Arm | Type | Receives |
|---|---|---|
| Azathioprine | Experimental | Drug: AzathioprineAzathioprine 2-2.5 mg/kg/day, according to approved indication |
| Infliximab | Active comparator | Drug: InfliximabInfliximab 5 mg/kg every 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 -65 years
- Written informed consent and willing to adhere to study procedures.
- Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (a maximum interval between two infusions of ± 3 weeks is allowed)
- Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
- Global Mayo score at baseline ≤ 2
Key exclusion criteria (8 listed)
- Disabling and persisting extraintestinal manifestation at baseline
- Patients unable to comply with study procedures
- Known intolerance or previous allergic reaction to thiopurines
- Concomitant therapy with allopurinol
- Any disease not compatible with the use of infliximab or azathioprine, as per clinician's judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineAZA treatment after IFX withdrawal for maintenance of remission | Drug | Azathioprine |
| InfliximabIFX treatment for maintenance of remission | Drug | Infliximab |
Primary outcome
Relapse rate
Time frame: 12 months
relapse rate in the two study groups.
4 secondary outcomes
Relapse time
Time frame: 12 months
Number of adverse events [Safety and Tolerability]
Time frame: 12 months
Number of serious adverse events [Safety and Tolerability]
Time frame: 12 months
Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Derived from this study: PubMed 40013523Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azathioprine and Infliximab in people with Colitis, Ulcerative, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Danese, MD, PhD (+390282245555, IBDclinicaltrials@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.